FDA plans to change fine-print warnings to combat wrong prescriptions

Published: Friday, December 22, 2000

WASHINGTON {AP} Hoping to combat the dangerous problem of doctors prescribing the wrong drug for the wrong patient, the government said Thursday it would overhaul the fine-print drug warnings doctors are supposed to read so they can quickly spot hazards and keep risky medicines away from people they might kill.

Admitting that too few doctors today even read vital drug warnings, the Food and Drug Administration said the change will let busy physicians spot in 30 seconds a medicine's biggest danger.

It's the FDA's latest effort to improve drug safety in the wake of a string of banned drugs that killed dozens of Americans.

"I think we'll see a real difference," said FDA Commissioner Jane Henney. Patients "will have a greater assurance that the drug prescribed will be the right one."

Every medicine, even aspirin, comes with side effects. A drug that's safe for one person can kill the next. Indeed, studies estimate 2 million Americans are hospitalized annually with drug side effects, and 100,000 die.

So each new prescription drug comes with pages of complex warnings, written in fine print, that tell doctors how to match each patient's risk factors with each drug's side effects.

But few doctors read these labels, instead learning about new drugs from pharmaceutical salesmen unlikely to emphasize the risks.

The FDA proposed regulations to make the labels of newer drugs easier for doctors to use, with at-a-glance sections of the most important safe-prescribing information. Among the changes:

Each label will begin with a "highlights" section, leading with the most important warning. Take the blood pressure drug Capoten. Its label would state up front, in bold print, that use in the second or third trimester of pregnancy can kill a fetus.

Next, doctors learn if additional warnings have been added in the last year, so they can check an update they might have missed.

Then comes the proper dose.

Next come other important side effects and, in bold print, the FDA's phone number to report suspected problems in patients. This is a major change. The FDA depends on doctors voluntarily reporting their patients' problems to uncover previously unknown drug risks, yet few do.

Doctors can then read the label's old-fashioned details, using a new index to each topic instead of slogging through all the tiny type.